Immunovant, a majority-owned Roivant subsidiary, reported on September 23, 2026 that a 57-patient randomized, double-blind, placebo-controlled proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus did not reach statistical significance on percent change in CLASI-A score at week 12. The company reported numerical trends favoring the drug and an association between deeper IgG reductions and clinical response, but said the results did not meet its internal bar and it will stop development in the indication. Trials of the FcRn inhibitor continue in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, CIDP, and Sjögren's disease.
Novartis (NYSE: NVS) initiated clinical holds on all rap-cel (YTB323, an autologous CD19-directed CAR-T cell therapy) autoimmune trials on August 24, 2026 following three fatal cases of immune effector cell-associated hemophagocytic syndrome, a rare life-threatening inflammatory reaction. Affected trials cover lupus (systemic lupus erythematosus), myasthenia gravis, multiple sclerosis, systemic sclerosis, idiopathic inflammatory myopathies, and additional autoimmune indications. Bristol Myers Squibb (NYSE: BMY) voluntarily paused enrollment in its own zola-cel (zolacabtagene autoleucel, another autologous CD19 CAR-T) autoimmune trials after detecting transient and reversible inflammatory events during routine safety surveillance; BMS had halted the enrollment in June 2026 after cases of brain inflammation but did not publicly disclose the pause until three months later. Novartis and BMS were the leading commercial-scale CAR-T-in-autoimmune-disease players; the paired pauses are a substantial setback for the category, which had been the hottest cell-therapy expansion area of 2026 after Kyverna, Cabaletta Bio, and multiple academic centers reported dramatic clinical responses in refractory lupus and neurological autoimmune disease.